Vice-Premier Wu Yi yesterday ordered a thorough review of
pharmaceutical production licenses and certificates amid a widening
probe into the scandal involving the former head of the national
food and drug watchdog.
Production licenses for nearly 170,000 medicines will be
reviewed under strict assessment procedures by the end of the
year.
In a national video-conference, Wu singled out drugs which were
granted national-level production licenses from 1999 to 2002 as the
focus of inspection.
Wu's action is seen as a major effort to reorganize the
disorderly drug market the legacy of the disgraced former head of
the State Food and Drug Administration (SFDA), Zheng Xiaoyu.
Zheng, 63, is being investigated for taking bribes during his
eight years in office since 1998.
Insiders said there was rampant corruption involving the SFDA
after Zheng introduced the Good Medicine Product (GMP) certificate
to replace local standards.
By 2003, more than 2,000 drug producers had been awarded GMP
certificates, compared with only 87 before 1999.
"It was an open secret that without money, getting a GMP
approval or national production license was impossible," Business
News quoted an unnamed drug producer as saying.
Besides reviewing GMP approval and production licenses, Wu also
ordered that quality inspectors be dispatched to factories which
make key drugs such as injections, biomedicine and special
medicines.
There were a series of injection-related medical accidents last
year, including the Xinfu antibiotic made by Anhui-based Worldbest
Bio-pharmaceutical Co, which claimed 11 lives.
Wu criticized "unscrupulous drug authorities", and called for
strict administrative and legal penalties to be imposed on corrupt
officials and drug producers.
"Fines alone will not be enough. All those people should face
the full force of the law," said Wu.
She admitted that the drug supervision system has severe
loopholes, ranging from loose rules which could be changed by some
officials to suit their own interests to lax supervision.
In the past few years, the SFDA handled more than 10,000
applications for registering new drugs annually, compared with 148
in the United States in 2004.
To clean up the industry, drug supervision authorities revoked
the business licenses of 160 drug manufacturers and retailers in
2006.
Hao Heping, former director of the department of medical
equipment in charge of issuing production licenses, was sentenced
to 15 years in November for corruption.
(China Daily?February 9, 2007)